DEVICE: Mini Battery Pack for RONDO grey 100 cm (09008737099862)

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Device Record History
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Device Identifier (DI) Information
Mini Battery Pack for RONDO grey 100 cm
09986
In Commercial Distribution

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09008737099862
GS1

1
300764032 *Terms of Use
Audio Processor Battery Pack
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Device Characteristics
MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58185 Cochlear implant/auditory brainstem implant battery
An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MCM IMPLANT, COCHLEAR
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P000025 029
P000025 039
P000025 043
P000025 050
P000025 051
P000025 052
P000025 059
P000025 104
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b7543449-ec89-41ae-b7dd-55b332262093
September 14, 2022
6
December 03, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(888)633-3524
implants.us@medel.com
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